Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific
Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific (North Carolina): 510(k) cleared for Ibt Scientific. Its amount of 28 is below the median of 138 (6th percentile). Dated 19 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 28 · 6th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related NC FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263267 |
| Device | Endox Test Strips |
| Applicant | Ibt Scientific |
| Specialty / panel | General Hospital |
| Product code | JOJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-09-18 |
| Decision date | 2026-10-16 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | Creedmoor, NC, US |
| amount percentile | 6th of 414 (median 138, 0.2x median) |
| Peer records CSV (9 NC records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific and 9 North Carolina peers
- North Carolina FDAPulse records like this one: 9
- Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific's amount: 6th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every North Carolina peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 28-day review: this device is a strong predicate for similar products.
- Posted 19 days ago.
What is the FDAPulse record for Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific in North Carolina?
Endox Test Strips (K263267) by Ibt Scientific was cleared on 2026-10-16 after 28 days of review.
How does Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific compare to other North Carolina FDAPulse records?
Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is 19 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Endox Test Strips (K263267) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Endox Test Strips (K263267) | NC | 2026-10-16 |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| Endox High Level Disinfectant (K254094) | DE | 2026-10-16 |
| Carecube Negative Pressure Isolation Chamber (1BY) (K260180) | CA | 2026-10-16 |
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